Recent developments
of the

Endocrine Disruptor
Screening and Testing Advisory Committee (EDSTAC)

including a
summary of EDSTAC's final report

Davis Baltz /
Commonweal 28aug98

This document reports on recent developments of the Endocrine Disruptor
Screening and Testing Advisory Committee (EDSTAC), including a summary of
EDSTAC's final report. EDSTAC was chartered by the U.S. Environmental Protection
Agency (EPA) in October 1996 to develop recommendations for EPA about how to
screen and test chemicals for their potential to disrupt hormone function in
humans and wildlife, based on provisions of the 1996 Food Quality Protection Act
and the reauthorization of the Safe Drinking Water Act. EDSTAC was established
under the provisions of the Federal Committee Advisory Act (FACA), and has been
chaired by Dr. Lynn Goldman, EPA Assistant Administrator in the Office of
Prevention, Pesticides and Toxic Substances.

EDSTAC met publicly nine times in different U.S. cities, beginning with San
Francisco in December 1996. EDSTAC's final plenary was June 17-18 1998 in
Washington D.C. The committee also visited Houston, Baltimore, Chicago, New
York, and Orlando.

The EDSTAC is composed of approximately forty stakeholders drawn from
industry, academia, government agencies, and public interest and environmental
organizations. A full list of members, as well as other documents, including the
draft report, is available from this EPA website:

EDSTAC met for the final time face-to-face on June 17-18, 1998 in Washington
D.C. The original deadline for completing the report has slipped. Now it appears
the first of September 1998 will see the final report released to EPA.

2. EPA WILL SOON ISSUE ITS PROPOSED SCREENING AND TESTING PROGRAM

It is expected that EPA will formally issue its proposed program in detail in
early fall, 1998 in a detailed Federal Register announcement. EPA's proposal
will be largely based on EDSTAC's recommendations, and its announcement will
initiate a formal 60 or 90 day nationwide public comment period and scientific
peer review by a first-ever combined panel of the EPA's Science Advisory Board
(SAB), and the EPA's Scientific Advisory Panel (SAP). The formal peer review is
now expected to take place in March 1999 instead of December 1998 as earlier
scheduled.

EPA may also decide to "roll out" its proposal with a press
conference and briefing. This is the first time in over 20 years that Congress
has spoken with regard to actually testing chemicals, and in the Agency's view,
the announcement of the proposed Endocrine Disruptor Screening and Testing
Program will be a significant step forward.

3. FUNDING FOR ONGOING ACTIVITIES WILL BE CRUCIAL

No matter what the details of the EPA's proposal are, locating the funds to
carry the screening and testing program forward is an extremely important task.
Initial key activities will revolve around the standardization and validation of
proposed assays; a recommended research project to address low dose issues; and
the implementation of High Throughput Pre-Screening. The costs will not be
inexpensive, and public funds will need to be resourced to carry the program
ahead. Once the assays are standardized and validated, the screening and testing
program will formally begin and presumably industry money will be used for its
operation.

4. PUBLIC COMMENT

After the EPA presents its proposed Endocrine Disruptor Screening and Testing
Advisory Program to Congress in the fall of 1998, there will be a formal,
nationwide public comment period of sixty or ninety days. This comment period
will be particularly important because comments will be directly to EPA on their
proposed program. The first six EDSTAC plenaries included public comment
periods, which were well-attended. A wide range of citizen interests appeared
before the committee to provide comment. With EDSTAC completing its work, the
opportunity to comment on the EDSTAC's work and report is over.

5. EDSTAC WILL PRESENT A CONSENSUS DOCUMENT

Barring a last minute, unexpected disagreement, the full EDSTAC will submit a
consensus document to EPA. EPA is pleased that EDSTAC has achieved consensus. It
had been the hope of the Agency from the beginning to have an agreed-upon set of
recommendations. The rationale has been: if all EDSTAC stakeholders across the
spectrum concur, then it will be much more feasible to have a screening and
testing program that gets on with the important business of assessing chemicals
for endocrine disrupting properties, as opposed to a system that becomes bogged
down by administrative challenges and litigation by various interest groups at
every step.

EDSTAC's consensus is a significant accomplishment that attests to the broad
concern across society about endocrine disruption. However, the EDSTAC has in
some cases left key decisions to EPA, meaning that important decision-making
will be made by EPA without the consensus backing of the EDSTAC panel.

6. EDSTAC WILL RECOMMEND A TIERED APPROACH

EDSTAC has long known a tiered approach would be recommended to EPA, and this
conceptual framework is not controversial. After an initial SORTING step,
chemicals will undergo PRIORITY SETTING which will determine, in essence, in
what order the chemicals will be screened and tested. The next step is TIER ONE
SCREENING, a first "rough cut" battery of assays, followed by TIER TWO
TESTING if necessary, which would provide much more comprehensive and specific
information. Chemicals which ultimately test negative, or are not prioritized
because of low concern, would be deferred until such time as new evidence
indicates they should be re-examined. Chemicals which ultimately test positive
as endocrine disruptors after Tier Two Testing would then undergo Hazard
Assessment at EPA.

A total of 87,000 chemicals will be available for the first Sorting step.
This includes the TSCA inventory, pesticides (active ingredients and inerts),
and ingredients in cosmetics and food additives in collaboration with U.S. FDA.

7. DESCRIPTION OF "ENDOCRINE DISRUPTOR"

At its final plenary, EDSTAC agreed on language to describe an
"endocrine disruptor." This had been a contentious issue from the
beginning. The language reads: "The EDSTAC describes an endocrine disruptor
as an exogenous chemical substance or mixture that alters the structure or
function(s) of the endocrine system and causes adverse effects at the level of
the organism, its progeny, and populations or subpopulations of organisms -
based on scientific principles, data, weight-of-evidence, and the precautionary
principle." It should be noted that EDSTAC chose to label this as a
"description" and not a "definition." Nearly everyone agrees
that it is too long, and rather klunky.

While industry is pleased that the final document includes "adverse
effects" language, the trade-off for public interest advocates is gaining
explicit mention of the precautionary principle. In addition, the document
states that the current level of knowledge and experience in endocrine disruptor
toxicology "do not permit the simple categorization of all endocrine
effects into adverse and non-adverse," reflecting some EDSTAC members'
concern that it can be very difficult to recognize adverse effects, particularly
at the population level.

The difficulty agreeing on a definition stemmed primarily from the question
of whether or not the phrase "adverse effects" should be included.
Industry consistently pushed the position that an "endocrine
disruptor" must not only alter the structure or function of the endocrine
system, but also cause adverse health effects. In other words, evidence of a
synthetic chemical binding to receptors would not be "disruption"
unless it was shown that this binding then led to adverse health effects.

Public interest representatives have said that the interference in the
functioning of the hormone system caused by receptor binding (or another
mechanism) is evidence enough to cause concern. Waiting for adverse effects,
which may not become manifest for a generation, irresponsibly allows chemical
exposure to continue that might be harmful. There is enough evidence now to
warrant the exercise of more precaution to protect the public from exposure to
potential endocrine disrupting chemicals.

Because the EDSTAC description of an endocrine disruptor contains the
"adverse effects" language, industry has insisted that the final
document be mostly cleansed of the word "disruptor." Industry does not
want anything to be labeled as a "disruptor" unless and until adverse
health effects have been demonstrated at the conclusion of Tier Two Testing.
Until that time, industry prefers to refer to chemicals in the program that test
positive as "endocrine active" or "endocrine-mediated."
Industry's concern is that any "tag" of endocrine disruptor will put
great pressure on a chemical for product de-selection, voluntary or otherwise.

EDSTAC recognized that the statutory requirements of the Food Quality
Protection Act and the Safe Drinking Water Act would drive some chemicals
towards early screening and testing regardless of EDSTAC recommendations. For
Priority Setting, EDSTAC concentrated on putting forth its best suggestions
based on public and environmental health concerns rather than on existing
regulatory requirements.

EDSTAC recommendations in Priority Setting exceed what would be required
solely by statute in some significant ways:

* EDSTAC recommends EPA consider a much larger universe of chemicals as
potential candidates for screening and testing (87,000).

* EDSTAC recommends EPA's screening and testing program should address
environmental impacts, and focus on both human and ecological health.

* EDSTAC recommends that mixtures be considered.

9. EPA WILL HAVE TO COMPLETE THE PRIORITY SETTING PROCESS

EDSTAC has recommended several criteria for EPA to use in the Priority
Setting process by which chemicals will enter the screening and testing program.
Five of these pertain to "exposure," three pertain to
"effects," and "exposure and effects" together comprise
another criterion to consider. Together with special cases such as mixtures or
nominations, each of these "compartments" would contribute some
unspecified number of chemicals for each phase of the screening and testing
program. This approach came to be known as the "compartment-based"
method of Priority Setting.

The EDSTAC began work building a powerful database tool which incorporates
the Priority Setting criteria. Due to time and resource constraints, however,
EDSTAC was not able to complete the database, but recommends that EPA carry it
through to completion with multi-stakeholder involvement.

This database will be a crucial tool to ask "what if" questions for
determining which chemicals should receive a high priority for early screening
and testing. EDSTAC recognized that Priority Setting is a value-laden process no
matter who is doing it, and therefore attempted to construct a prioritization
system in which the values of those setting priorities would be evident.

It is left to EPA to generate a list of named chemicals to enter the program
first, as well as a minimum number to enter each phase of the program. No matter
what the Agency decides, it will almost certainly anger some stakeholders.

The database will be an immensely useful source of information for the
public, and public interest representatives on EDSTAC want to ensure that it is
available to everyone. The fact that a multi-stakeholder process is envisioned
for the database's future development is evidence of the sensitive nature of how
the database could be used.

10. 'WEIGHT OF EVIDENCE' DECISION-MAKING WILL BE LEFT TO EPA

How will screening and testing results be interpreted? What level of proof
should be required to send a chemical to the next tier of scrutiny? In most
cases, interpreting the results from a series of assays, which could likely
include both positive and negative results, will require professional judgment.

EDSTAC is recommending that a "weight of evidence" approach be
utilized on what will mostly be a case-by-case basis. Many decisions may prove
to be straightforward - the weight of evidence will clearly indicate a consensus
path of action. But there will also be cases where equivocal evidence is in the
record, and EPA decisionmaking may be controversial.

11. HIGH THROUGHPUT PRE-SCREENING WILL QUICKLY GENERATE DATA

Because so many chemicals have no information whatsoever, EDSTAC will
recommend that High Throughout Pre-Screening (HTPS) be implemented. In HTPS,
chemicals are screened with a limited number of simple assays that can be
conducted by robotics technology. The technology exists to conduct this kind of
automated assay on thousands of chemicals per year. This relatively inexpensive
and fast process is a way to get more information quickly so that Priority
Setting can proceed more fully informed.

The assays recommended for HTPS are designed to show whether or not a
chemical binds to an estrogen, androgen, or thyroid receptor and causes
transcriptional activation of genes. The EDSTAC recommends that all chemicals
produced in excess of 10,000 pounds per year would be subjected to HTPS.
Currently, there are 15,000 chemicals which are produced at this level or
greater. The cut-off figure of 10,000 pounds was arrived at as a way to limit
the size of the task. EDSTAC also recommends that HTPS be performed on all
pesticides (active and inert ingredients), and on all chemicals proposed to
bypass a tier in the program (see below), regardless of production volume.

A demonstration project to assess HTPS's feasibility is underway, and a
contract lab has begun work assembling samples and running the HTPS assays on 78
substances selected to undergo HTPS. No results are available yet. Most EDSTAC
members are assuming that the demonstration project will be successful, in which
case the formal HTPS program could begin with some or all results available in
1999. If the HTPS system does not prove to be viable, the same information will
be gathered in Tier One Screening using already developed assays - but it will
be more expensive.

It is important the HTPS demonstration project be completed in a timely way
so the formal HTPS program can begin. HTPS results will enable Priority Setting
to proceed with more information to consider.

12. CITIZENS CAN NOMINATE CHEMICALS FOR CONSIDERATION

EDSTAC is recommending a nominations track in the program whereby individuals
or organizations can recommend chemicals for inclusion in the screening and
testing program. The primary objective is to capture chemicals that are not
identified by other means in Priority Setting, but are of concern to communities
or populations that might have disproportionately high exposure.

Nominating organizations will be made public. Nominating individuals will be
able to request anonymity if they do so in writing. For each phase of the
program when a new group of chemicals is poised to enter Tier One Screening,
EDSTAC recommends that no less than five percent be drawn from nominated
substances which were not selected by another prioritization criterion.

13. DEVELOPMENTAL ASSAY IS MISSING FROM TIER ONE SCREENING

The recommended Tier One Screening battery does not contain an assay that
looks at early developmental exposure. Since irreversible effects from endocrine
disruption may occur during these developmental life stages, the lack of an
assay that examines prenatal or pre-hatch exposure is a shortcoming of the
recommended EDSTAC battery and a compelling concern. Some SAB/SAP peer reviewers
specifically mentioned to EDSTAC that it would be useful to know how embryonic
tissue could be looked at in more detail in Tier One Screening.

EDSTAC recommends that EPA take "affirmative steps" in
collaboration with stakeholders to develop a protocol for a full life cycle
developmental exposure screening assay which would address embryonic exposure
and the evaluation of adult offspring. If developed, EDSTAC recommends the assay
should undergo validation and if validated, EPA should integrate it into the
existing Tier One Screening battery.

In its final report, EDSTAC suggests one in utero developmental screening
assay for further research. Industry believes this particular assay is too
expensive, and is in fact a Test rather than a Screen that doesn't belong in a
Tier One Screening battery.

14. CHEMICALS WILL BE ABLE TO BYPASS TIER ONE SCREENING

The document contains recommendations for bypassing Tier One Screening in two
ways. The first is for chemicals that have previously been subjected to
two-generation reproductive toxicity tests, although not necessarily for all
endpoints of concern in endocrine disruption. The second way to bypass Tier One
Screening is for the owner of the chemical to voluntarily move directly to Tier
Two Testing without Tier One Screening results (or potentially any other prior
toxicology testing).

In both cases, all chemicals bypassing Tier One Screening would undergo High
Throughput Pre-Screening, and the "default" plan for Tier Two Testing
would be that all T2T assays would be run. In the first case, a bypass mechanism
means that "functionally equivalent" information can be substituted
for results that the endocrine disruptor screening and testing program itself
would generate.

What exactly does "functional equivalence" mean? EPA may likely
have to initiate a formal rulemaking to clarify this, even though EDSTAC offers
guidance by defining a screen or test as functionally equivalent to a Tier One
Screening or Tier Two Testing assay when it "provides equivalent
information for each endpoint being studied."

In both bypass options, skipping Tier One Screening could be problematic
because the chemical will enter Tier Two Testing with less information to tailor
its particular mix of Tests, including dose selection. The risk of false
negatives in Tier Two Screening could be elevated without the data provided by
Tier One Screening. (end of part one)

15. MECHANISM FOR ALTERNATIVE ASSAYS IN TIER ONE SCREENING

The recommended Tier One Screening battery is comprised of three in vitro and
five in vivo assays. In addition, EDSTAC is recommending alternative assays for
validation which could replace parts of the recommended battery in some
circumstances. These alternatives would be proposed for use when they yielded
information which was "functionally equivalent" to the first choice
battery, thus precluding the need to run full complement of assays in the first
choice battery. Whether the alternative assays will be capable of providing
equivalent information will be determined during the validation phase.

As is the case with bypassing Tier One Screening, the issue of
"functionally equivalent" information raises concerns because it would
usually mean that less information is used for decision-making. But if less
information is available, can it really be "equivalent?"

16. MECHANISM FOR ALTERNATIVES TO TWO-GEN REPRODUCTION STUDIES IN T2T

The final document recommends a full two-generation reproduction study for
Tier Two Testing, which is essential for some of the most important endpoints of
concern. At the same time, however, industry has successfully added a mechanism
whereby the full two-generation study can be replaced by either a less
comprehensive study call the Alternative Mammalian Reproduction Test (AMRT), or
a one-generation test. Both of these will begin the validation process, along
with other EDSTAC-recommended assays and tests.

The AMRT or one-generation test would be proposed for use when
"functionally equivalent" information could be generated using these
alternative assays, with or without existing information, thereby precluding the
need for a full two-generation reproduction study.

Industry wants to limit the multi-generational studies both because they cost
more, and because this is where they have the most to fear because of heightened
sensitivity during developmental life stages. While the AMRT and one-generation
test look at developmental life stages, they are considerably more limited than
a two-generation reproduction study in looking at both the timing and life
stages when exposure occurs.

17. TIER TWO TESTING WILL BE CONSIDERED DEFINITIVE

Industry has always wanted an assurance that a negative Tier Two Testing
result would be definitive; i.e., if a chemical tested negative in Tier Two
Testing, then it would be fully exonerated and shown NOT to be an endocrine
disruptor (at least unless or until new information is presented). While EDSTAC
acknowledges that there may be cases where the evidence is mixed about a
chemical's endocrine disrupting properties, it recommends that a negative result
in Tier Two Testing should be definitive because Tier Two Testing results carry
more weight than other information.

Industry wants to avoid any label of "endocrine disruptor" for a
chemical substance until all screens and tests have been completed and the final
result is positive. Industry's attraction to the bypass idea for Tier One
Screening is based in part on avoiding the ambiguous status of a positive Tier
One Screening result. Even though everyone is in agreement that a positive Tier
One Screening result will not count as sufficient evidence to arrive at a final
conclusion about a chemical's endocrine disrupting potential, much less trigger
regulatory action, industry feels strongly that the stigma of a positive Tier
One Screening result will unfairly prejudice the public against the chemical
substance with detrimental effects in the marketplace.

18. THYROID EFFECTS

During EDSTAC's life, there were concerns that proposals to detect thyroid
effects in Tier One Screening were inadequate. It was acknowledged that in
general, the dataset for thyroid is not as complete as for estrogen or androgen.

A frog metamorphosis assay was added to the Tier One Screening battery to
help address this. From what is known, thyroid disrupting chemicals usually act
through non-receptor-mediated mechanisms, and the frog metamorphosis assay was
added because it is believed to be relatively sensitive to thyroid disruption.
Public interest organizations on EDSTAC pushed to include as much language as
possible emphasizing that neuro-developmental endpoints always need to be
considered if there is any question of thyroid effects, and also if the chemical
skips Tier One Screening.

19. POLYMERS

Of the more than 87,000 synthetic chemicals now in existence, some 25,000 are
polymers. Because the monomers and oligomers which comprise the polymer are more
biologically active than the larger, intact polymers, the EDSTAC is recommending
that the focus should be on screening and testing the monomers and oligomers.
Another reason to focus on them is because of the daunting complexities of
studying whole polymers.

EDSTAC recommends that all polymer components should be prioritized within
the context of the "compartment" approach, along with additives and
degradates. In addition, EDSTAC recommends that all "small" polymers
be prioritized for screening.

EDSTAC is recommending that "large" polymers with a number average
molecular weight (NAMV) of more than 1,000 daltons be deferred because their
size would prevent their penetration through a cell membrane, based on studies
of aquatic organisms and the intestinal systems of mammals. There is some
controversy about the cut-off of 1,000 daltons. Although this figure is already
used as a regulatory threshold, research was cited during EDSTAC deliberations
suggesting neonates are able to absorb much larger molecules than adults because
they do not undergo "intestinal closure" until the age of 4-5 months.
The young of animal species could be vulnerable in the same way. These citations
are included in the report even though the 1,000 daltons threshold remains.
Presumably, these particular chemicals of concern would enter the screening and
testing program by receiving a high priority in another "compartment."

EDSTAC is also recommending that all "old" polymers (those that
were included in the first published TSCA inventory of 1979) be deferred as
"existing chemicals" for which little information exists. Public
interest representatives have said that just because a polymer is
"old" does not mean it should be grandfathered with a deferment. There
is very little known about these chemicals - EPA does not even know the NAMV for
polymers that were in existence before 1979, although all the monomers have a
CAS number.

If any of these component monomers or oligomers, from any polymer, tested
positive as an endocrine disruptor, EDSTAC is recommending that the component
proceed to hazard assessment. In addition, EDSTAC is recommending that an
exposure assessment be performed at this time to gauge the potential for
exposure from the intact polymer.

There is a concern because polymers can degrade over time, and EDSTAC is not
recommending that EPA create degradation conditions in the screening and testing
program. While degradates can enter the screening testing program via another
"compartment" (assuming there is existing information), the report
states that "EDSTAC does not consider it necessary to give special
consideration to the potential degradates of polymers."

From a public interest perspective, if a monomer or degradation product tests
positive, it would be prudent to classify the polymer itself as positive. The
point should be "to test the yogurt container after it has been through the
dishwasher, not before yogurt is put into it in the first place."

20. SIX MIXTURES RECOMMENDED FOR STUDY

The EDSTAC recommends six specific mixtures for initial scrutiny in the
screening and testing program. They are:

1. contaminants in human breast milk;

2. phytoestrogens in soy-based infant formulas;

3. mixtures of chemicals most commonly found at hazardous waste sites;

4. pesticide/ fertilizer mixtures;

5. disinfection byproducts;

6. gasoline.

EDSTAC acknowledges that screening and testing mixtures is a vastly
complicated undertaking. For example, can standardized presumptive mixtures even
be developed? That is, will a mixture to be tested change significantly from
sample to sample? This in itself will be a large hurdle to overcome. It was also
noted during EDSTAC deliberations that a positive result on a single mixture
would create a large and possibly unwieldy follow-up program by itself.

21. NATURALLY OCCURRING NON-STEROIDAL ESTROGENS WILL ENTER THE PROGRAM

Naturally occurring non-steroidal estrogens (NONEs) are derived from plants
and fungi. They are ubiquitous in food. EDSTAC is recommending that six
representative groups of NONEs enter the screening and testing program to
compare them with hormones and synthetic chemicals. In addition, one mixture of
NONEs is recommended (phytoestrogens in soy-based infant formulas). There is
evidence that some NONEs are safe and beneficial to humans, and humans
metabolize them relatively rapidly. However, their effects, particularly from
exposure in large amounts during developmental life stages, are not well
studied.

22. LOW DOSE TESTING

Low dose testing issues have been among the most controversial EDSTAC has
addressed. The concern is that some chemicals seem to have effects at low doses
which are not seen at higher doses, including neuro-developmental effects which
are emerging quickly in this regard. If developmental effects are not adequately
addressed at all relevant doses, including current environmental
"background" levels, a vital piece of the screening and testing
program's mission will be missed.

Industry has downplayed the significance of existing low dose research
because of the profound market implications it has for specific chemical
products and for the concept of risk assessment in general. During EDSTAC
deliberations, industry representatives said that in terms of hurdles to their
ultimate sign-on to the EDSTAC document, the low dose issue was their "Mt.
Everest" and they would not allow their products to be "held hostage
to ten mice."

Over the course of the 20 months since EDSTAC first met, there has been
broader public acceptance of low dose effects in the scientific community. A
workshop entitled "Characterizing the Effects of Endocrine Disruptors on
Human Health At Environmental Exposure Levels" was conducted May 11-13,
1998 in North Carolina by National Institute of Environmental Health Sciences
(NIEHS). The research findings presented at this workshop helped convince some
who had claimed that low dose research already conducted had not been
replicated. In addition, some of the SAB/SAP peer reviewers for EDSTAC, who met
in Washington D.C. on May 5-6, 1998, provided initial feedback to EDSTAC
expressing support for a more detailed examination of low dose issues.

The EDSTAC did not agree on a specific protocol to recommend dose levels.
However, the committee recommends the following features for low dose issues in
the screening and testing program:

* For in vitro assays in High Throughput Pre-Screening (HTPS) and Tier One
Screening, several dose levels are recommended (five plus a control) to develop
a dose response curve and an assessment of relative potencies. The goal is to
establish a 50 percent response rate for receptor activation relative to a
positive control which is known to bind to receptors. Presumably, this would
require some relatively low doses.

* For in vivo assays in Tier One Screening, EDSTAC recommends that the
decision to use one or more dose levels be determined subject to the validation
process. Information to assist decisionmaking would include existing data, HTPS
results, and range finding studies. Public interest representatives have been
very uncomfortable with a recommendation of a single high dose for in vivo Tier
One Screening. The reason is that it creates the potential for a chemical to
test negative at one high dose and then be deferred from further scrutiny
without ever undergoing low dosing levels in a whole-animal (in vivo) screen.

* In Tier Two Testing, EDSTAC agrees that special attention should be paid to
setting the low dose. Deciding dose levels in Tier Two Testing will rely on
existing information (including HTPS and Tier One Screening results),
environmental exposure where appropriate, and range-finding studies that include
low-dose sensitive endpoints.

* EDSTAC believes that a "recommended project to address low dose
issues" is required to resolve the underlying uncertainties and controversy
about dose selection and the identification of a
no-observed-adverse-effect-level (NOAEL). EDSTAC provides a suggested time frame
for the project of 4-6 months. It will be important for EPA to quickly take
steps to carry this out. In a similar way, EPA must build a mechanism into its
overall screening and testing program to quickly consider and incorporate new
scientific evidence.

* If the results of the low dose project demonstrate the need to include any
additional hormonal endpoints (i.e., androgen and thyroid which EDSTAC have
agreed should be addressed), re-testing of chemicals which have already passed
through the screening and testing program would be required for these additional
endpoints.

* If the results of the low dose project demonstrate the need to include
additional low doses, re-testing of chemicals would be required of chemicals
which had already tested positive at a high dose. However, re-testing of
chemicals which had already tested negative at a high dose would not be required
(unless other new information on the chemical would warrant it).

23. SOME COST REFERENCES WILL APPEAR IN DOCUMENT

Industry argued that the costs of implementing the screening and testing
program should be considered in deciding which screens and tests to run. Their
concern is to hold down the costs of the program which they will largely pay
for.

Public interest groups wanted to see all mention of costs expunged from the
document. They argued that the screening and testing program should focus on the
protection of public and environmental health, utilizing the most effective and
appropriate tools without regard to how much they cost.

Some references to cost will appear in the document. For example, in High
Throughput Pre-Screening, the document says that "the cost of performing an
assay needs to be taken into account...as high cost may limit the number of
chemicals that can be evaluated."

On the other hand, the report notes elsewhere that cost estimates (for
validation in this case) are "both preliminary and uncertain given the
inherent uncertainties regarding the outcome of the validation...process."
Public interest language was also inserted saying, "The EDSTAC notes that
these cost estimates should be viewed in the context of the near- and long-term
public health and environmental protection benefits to society."

24. AN EFFECTIVE COMMUNICATIONS STRATEGY WILL BE IMPORTANT

EDSTAC recognizes that an effective EPA communications system is crucial for
the success of the new Endocrine Disruptor Screening and Testing Program, both
for the public's right-to-know, and to prevent the misuse of information.

EPA will need to develop explanatory materials about the screening and
testing program, including the Nominations mechanism, to respond to expected
public interest and requests for information. Some constituencies which may have
particular concerns, such as environmental justice advocates, disease-impacted
groups, farm workers, or downstream industries, may need tailored information
about the program, and EDSTAC recommends that EPA be prepared to deliver this as
necessary.

EDSTAC is recommending that a tracking system be developed that allows the
public to quickly ascertain the status of any chemical in the program. This
would be available through an interactive website and other means. In addition,
regular program updates would be generated by EPA and communicated to
stakeholders who expressed an interest in receiving them.

25. RAPID AND GOOD-FAITH EFFORTS DURING VALIDATION WILL BE KEY

The EDSTAC recognizes that the screens and tests it is recommending will need
varying levels of standardization and validation before the program can formally
begin. It is important that standardization and validation occur quickly, so the
actual screening and testing program can begin as soon as possible. EDSTAC
recommends that standardization and validation be pursued on an
"accelerated schedule" because it is of the "highest
priority."

There is ample potential for foot-dragging delays if industry does not make
good faith efforts to move forward on the validation process. It is important to
note that the bar is being set very high for validation of assays in the context
of the endocrine disruptor screening and testing program.

From a public interest perspective, putting a time limit on the validation
process could be one way to drive it forward.

There is agreement that once an assay is validated, it can begin to be used.
It will not be necessary to wait for the entire Tier One Screening or Tier Two
Testing batteries to be validated before individual screens and tests can begin
to be run. On the other hand, industry may try to insist that all endpoints
being looked at in a particular screen or test be validated before the screen or
test can be used.

To carry the validation work forward with EPA, a post-EDSTAC non-FACA
"operational" committee of government, industry, academic and public
interest representatives is envisioned and in fact has already begun to meet.
This committee will likely also take on the further development of the
prioritization database, the evaluation of High Throughput Pre-Screening, and
other Priority Setting issues.

Standardization and validation costs will not be inexpensive. Some
combination of public and private funds need to be resourced to pay for this
next key step.

I am a member of the public who has tracked EDSTAC's work from a public
interest perspective, and am reporting on the committee's work in my own
capacity. During the life of the EDSTAC committee, I encouraged the public to:
attend remaining plenaries; provide pertinent public comments; and educate their
colleagues about endocrine disruption. Early in the EDSTAC process, I was
recruited to join EDSTAC's Communication & Outreach Work Group as a member
representing the public.

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